Guides & Documents

Questions and Answers on Annex 1

With the questions and answers we want to provide support for the implementation of Annex 1. The answers to the questions we received during past events are based on the opinions and experiences of the members of the Annex 1 Task Force, the CCS Task Force as well as on the answers of the speakers at the events.

Find out more about the Q&A document and get your free copy of the Questions and Answers on Annex 1.

ECA Equipment Design Guide

The purpose of the ECA's GMP Equipment Design Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made. To this end, the guidance contains numerous references and points of contact, a sort of a road map, that offers detailed information on the requirements or ways of proceeding for individual cases.

Find out more about the document and get your free copy of the ECA GMP Equipment Design Guide.

Contamination Control Strategy Task Force

According to the latest draft of the revision of EU GMP Annex 1 an overview strategy is required for the area of contamination control that links the various aspects of contamination control and associated measures, records the interactions and facilitates a corresponding analysis for gaps in the system. This can be used in existing companies to meaningfully record, coordinate and supplement existing measures or, in newly emerging facilities, to coordinate the implementation of the necessary contamination control measures across departments.

ECA´s Task Force on Contamination Control Strategy prepared a Guideline document that supports the user in creating a CCS, building up the documentation (comparable to a Site Master File – SMF) and thereby fulfilling the requirements of EU GMP Annex 1.

ECA Task Force on Contamination Control Strategy - Guide How to Develop and Document a Contamination Conrtrol Strategy

European QP Association

The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). These requirements have been extracted from the relevant documents and are summarized in a Good Practice Guide developed by the European QP Association. A number of responsibilities as well as requirements for continuous training for QPs are not defined in detail in the EU Directive and Guides. This Good Practice Guide – considered a "living document" – gives recommendations to QPs. The Guide is available for download if you register for the Association.

ECA Good Practice Guide "Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU" - Version 8.0.

Pharmaceutical Microbiology Group

The group was founded as Rapid Microbiological Methods (RMM) Working Group on 7 June 2006. It reviewed the current situation of RMM in Europe. In the following years it supported group members with current information about the development, implementation and validation of RMM. To move forward to a harmonised thinking, the group further provided literature lists, best practice papers and guideline lists on its website. Today the scope of the activity is broader. Therefore the group was renamed to Pharmaceutical Microbiology Group. Its paper/guidance document is available for download if you register for the Group.

ECA Guidelines for the Evaluation and Investigation of Microbiological Deviations

  • Chapter 1 - Deviation Handling of Microbiological Environmental Monitoring Excursions in Non-Sterile Pharmaceutical Manufacturing
  • Chapter 2 - Lab Investigations – Endotoxin Out of Specification (OOS)/ Out of Trend (OOT)/ Atypical Results Investigations
  • Chapter 3 - Guidance for Sterility Test Failures

Analytical Quality Control Group

The ECA Working Group on Analytical Quality Control was founded in 2010 in order to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. Version 2 of the ECA OOS SOP has already been available for all ECA members since 2013. Given the complexity of the topic, it was decided that the handling of OOT and OOE results need to be addressed in a separate guideline SOP, since there is both a lack of knowledge in the industry and a lack of guidance for trend analysis from the regulators in spite of increased regulatory interest in this area. The documents are available for download if you register for the Group.

Analytical QC Group Guidances & SOPs

  • ECA Standard Operating Procedure (SOP): Laboratory Data Management - Out of Specification (OOS) Results
  • Laboratory Data Management Guidance: Out of Expectation (OOE) and Out of Trend (OOT) Results
  • Laboratory Data Management Guidance - Analytical Procedure Lifecycle Management (APLM)

Validation Group

Qualification and Validation (Q&V) activities can be very time consuming, expensive and causing delay of new products to market, facility expansions etc. The purpose of this guide is thus to streamline Q&V by enabling a better cooperation and mutual understanding between customers and suppliers on projects related to pharmaceutical manufacturing systems, including equipment, facilities and utilities.

The ECA was one of the first organisations which published a Good Practice Guide regarding the new FDA Process Validation Guidance. With the revision of the Annex 15 also this Good Practice Guide has to be updated. As 1st revision the guide contains on one hand the main elements of the new validation approaches ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do").

Validation Group Guidance Documents

  • Good Practice Guide "Integrated Qualification and Validation - A guide to effective qualification based on a Customer-Supplier Partnership"
  • ECA Good Practice Guide on Validation

GDP Association

It is of key importance that medicinal products are not only manufactured in a high quality in accordance with Good Manufacturing Practices, but that the quality and integrity of these products are maintained throughout the entire supply chain up to the patient. This is where Good Distribution Practice (GDP) comes into play. The GDP Interpretation Guide was published jointly by the ECA Foundation GDP Association and the Pharmaceutical Quality Group (PQG). It’s intention is to help colleagues in industry with the implementation of the EU GDP Guideline. The Guide is available for download if you register for the Association.

ECA/PQG Guidance on the Interpretation and Implementation of European Good Distribution Practice &
ECA/PQG Guidance on the Interpretation and Implementation of European Good Distribuition Practice for Active Substances

The Code of Practice has been developed to support Responsible Persons according to EU GDP Guide 2013/C343/01. It provides information about the responsibilities and duties of RPs as well as recommendations for education and ongoing training. Finally an example of a job description should help RPs to define their role in the supply chain of medicinal products. This Guide is also available for download if you register for the Association.

ECA Code of Practice for The Responsible Person for GDP

Visual Inspection Group

This group’s best-practice-paper aims at highlighting best practices for carrying out 100 % visual inspection of medicinal products for parenteral use in the pharmaceutical industry. It should be seen as addition and supplement to the monographs of the different Pharmacopoeias. Visual inspections of medicinal products for parenteral use should detect any readily identifiable visible container defects and ensure constant quality of the product in terms of absence of particular matter and/or turbidity, and correct or uniform appearance of a lyo cake. The Guide is available for download if you register for the Group.

Visual Inspection Group Guidance Documents & Best Practice Paper

  • ECA Good Practice Guide “Visual Inspection of Medicinal Products for Parenteral Use - Version 3.2"
  • Container Closure Integrity Testing of Medicinal Products for Parenteral Use - Position Paper - Version 2.0

Data Integrity & IT Compliance Group

The best-practice-paper was originally developed by the ECA Data Integrity & IT Compliance Group’s Advisory Board. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. The documents are available for download if you register for the Group.

Data Integrity & IT Compliance Group Checklists & SOPs

  • ECA Audit Checklist - PaaS Service Providers
  • ECA Audit Checklist - SaaS Service Providers
  • ECA SOP - Selection Process for Cloud Service Providers

Data Integrity Task Force

Data Integrity has become one of the most frequently observed GMP deviations in FDA and EU Inspections. This is why the topic is currently in the centre of attention of both regulators and industry. The ECA Guidance Document covers - among others - the roles and responsibilities of Corporate and Senior Management in Data Governance as well as the necessary Policies, Procedures and Processes. It further provides information on establishing criteria for Data Integrity and security of records based on ALCOA+Principles and on Auditing for Data Integrity and security of records. You need to be an ECA Member to download the documents.

ECA Guidance Document - Data Governance and Data Integrity for GMP Regulated Facilities

Cannabis Working Group

Searching for answers to GMP and other regulatory questions is a time-consuming activity. The ECA Cannabis Working Group’s document – available exclusively at the respective events – is therefore intended to provide a source of information, summarizing GMP and other regulatory information and documents currently available on a global level. In addition, it provides useful comments and an Annex with further information. It is the intention of ECA ́s Cannabis Working Group to update this comprehensive collection regularly and to add new information on regulations and guidelines once they are available.

ECA Cannabis Roadmap - GMP Requirements and Regulatory Information on Medicinal Cannabis (and CBD Products) - Version 4.0

Annex 1 Task Force

In 2017, the first draft revision of Annex 1 of the EU GMP Guideline was published, resulting in more than 6.000 comments in the public consultation. After a detailed review, a second draft was published in February 2020. To avoid that comments already submitted and rejected in the first commenting phase would be submitted again, the European Commission this time resorted to a so-called "stakeholder consultation". This means that only selected organizations and interest groups were invited to submit comments - and only to pre-determined sections of the new draft and a small scope of important further comments. The ECA and the European QP Association (EQPA) also were invited to comment in this second phase. Below please find more information on the first comments from the specifically established Annex 1 Task Force as well as on the comments in the second targeted consultation.

Comprehensive Comments on the Annex 1 Revision from the Annex 1 Task Force

Joint letter from the ECA Foundation, European QP Association and Annex 1 Task Force in the second targeted consultation and Comments